[Federal Register Volume 72, Number 38 (Tuesday, February 27, 2007)]
[Notices]
[Pages 8747-8750]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-3258]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0427]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Reporting and 
Recordkeeping Requirements and Availability of Sample Electronic 
Products for Manufacturers and Distributors of Electronic Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995 (the PRA).

DATES: Fax written comments on the collection of information by March 
29, 2007.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the 
Chief Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1472.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance:

Reporting and Recordkeeping Requirements and Availability of Sample 
Electronic Products for Manufacturers and Distributors of Electronic 
Products (OMB Control Number 0910-0025)--Extension

    Under sections 532 through 542 of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 360ii through 360ss), FDA has the 
responsibility to protect the public from unnecessary exposure of 
radiation from electronic products. The regulations issued under these 
authorities are listed in the Code of Federal Regulations, title 21, 
chapter I, subpart J. Specifically, 1410.10 of the FDA Staff Manual 
Guide delegates administrative authorities to FDA.
    Section 532 of the act directs the Secretary of Health and Human 
Services (the Secretary), to establish and carry out an electronic 
product radiation control program, including the development, issuance, 
and administration of performance standards to control the emission of 
electronic product radiation from electronic products. The program is 
designed to protect the public health and safety from electronic 
radiation, and the act authorizes the Secretary to procure (by 
negotiation or otherwise) electronic products for research and testing 
purposes and to sell or otherwise dispose of such products.
    Section 534(g) of the act directs the Secretary to review and 
evaluate industry testing programs on a continuing basis; and section 
535(e) and (f) of the act directs the Secretary to immediately notify 
manufacturers of, and ensure correction of, radiation defects or 
noncompliances with performance standards.
    Section 537(b) of the act contains the authority to require 
manufacturers of electronic products to establish and maintain records 
(including testing records), make reports, and provide

[[Page 8748]]

information to determine whether the manufacturer has acted in 
compliance.
    Parts 1002 through 1010 (21 CFR parts 1002 through 1010) specify 
reports to be provided by manufacturers and distributors to FDA and 
records to be maintained in the event of an investigation of a safety 
concern or a product recall.
    FDA conducts laboratory compliance testing of products covered by 
regulations for product standards in parts 1020, 1030, 1040, and 1050 
(21 CFR parts 1020, 1030, 1040, and 1050).
    FDA details product-specific performance standards that specify 
information to be supplied with the product or require specific 
reports. The information collections are either specifically called for 
in the act or were developed to aid the agency in performing its 
obligations under the act. The data reported to FDA and the records 
maintained are used by FDA and the industry to make decisions and take 
actions that protect the public from radiation hazards presented by 
electronic products. This information refers to the identification of, 
location of, operational characteristics of, quality assurance programs 
for, and problem identification and correction of electronic products. 
The data provided to users and others are intended to encourage actions 
to reduce or eliminate radiation exposures.
    FDA uses the following forms to aid respondents in the submission 
of information for this information collection:
    FDA Form 2579 ``Report of Assembly of a Diagnostic X-ray System''
    FDA Form 2767 ``Notice of Availability of Sample Electronic 
Product''
    FDA Form 2877 ``Declaration for Imported Electronic Products 
Subject To Radiation Control Standards''
    FDA Form 3649 ``Accidental Radiation Occurrence''
    FDA Form 3626 ``A Guide for the Submission of Initial Reports on 
Diagnostic X-Ray Systems and Their Major Components''
    FDA Form 3627 ``Diagnostic X-ray CT Products Radiation Safety 
Report''
    FDA Form 3628 ``General Annual Report (Includes Medical, 
Analytical, and Industrial X-ray Products Annual Report)''
    FDA Form 3629 ``Abbreviated Report''
    FDA Form 3630 ``Guide for Preparing Product Reports on Sunlamps and 
Sunlamp Products''
    FDA Form 3631 ``Guide for Preparing Annual Reports on Radiation 
Safety Testing of Sunlamps and Sunlamp Products''
    FDA Form 3632 ``Guide for Preparing Product Reports on Lasers and 
Products Containing Lasers''
    FDA Form 3633 ``General Variance Request''
    FDA Form 3634 ``Television Products Annual Report''
    FDA Form 3635 ``Laser Light Show Notification''
    FDA Form 3636 ``Guide for Preparing Annual Reports on Radiation 
Safety Testing of Laser and Laser Light Show Products''
    FDA Form 3637 ``Laser Original Equipment Manufacturer (OEM) 
Report''
    FDA Form 3638 ``Guide for Filing Annual Reports for X-ray 
Components and Systems''
    FDA Form 3639 ``Guidance for the Submission of Cabinet X-ray System 
Reports Pursuant to 21 CFR 1020.40''
    FDA Form 3640 ``Reporting Guide for Laser Light Shows and 
Displays''
    FDA Form 3147 ``Application for a Variance From 21 CFR 1040.11(c) 
for a Laser Light Show, Display, or Device''
    FDA Form 3641 ``Cabinet X-ray Annual Report''
    FDA Form 3642 ``General Correspondence''
    FDA Form 3643 ``Microwave Oven Products Annual Report''
    FDA Form 3644 ``Guide for Preparing Product Reports for Ultrasonic 
Therapy Products''
    FDA Form 3645 ``Guide for Preparing Annual Reports for Ultrasonic 
Therapy Products''
    FDA Form 3646 ``Mercury Vapor Lamp Products Radiation Safety 
Report''
    FDA Form 3647 ``Guide for Preparing Annual Reports on Radiation 
Safety Testing of Mercury Vapor Lamps''
    In the Federal Register of November 3, 2006 (71 FR 64714), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    The most likely respondents to this information collection will be 
electronic product and X-ray manufacturers, importers, and assemblers.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                        FDA Form        No. of       Annual Frequency    Total Annual    Hours per
   21 CFR Section        Number       Respondents      per Response        Responses      Response   Total Hours
----------------------------------------------------------------------------------------------------------------
1002.3               .............              10                1                 10           12          120
----------------------------------------------------------------------------------------------------------------
1002.10              3626--Diagnos             540                1.6              850           24       20,400
                      tic X-ray
                     3627--CT X-    ..............  ..................  ..............  ...........  ...........
                      ray
                     3639--Cabinet  ..............  ..................  ..............  ...........  ...........
                      X-ray
                     3632--Laser    ..............  ..................  ..............  ...........  ...........
                     3640--Laser    ..............  ..................  ..............  ...........  ...........
                      Light Show
                     3630--Sunlamp  ..............  ..................  ..............  ...........  ...........
                     3646--Mercury  ..............  ..................  ..............  ...........  ...........
                      Vapor Lamp
                     3644--Ultraso  ..............  ..................  ..............  ...........  ...........
                      nic Therapy
----------------------------------------------------------------------------------------------------------------
1002.11              .............           1,000                1.5            1,500          0.5          750
----------------------------------------------------------------------------------------------------------------
1002.12              3629--Abbrevi             150                1                150            5          750
                      ated Report
----------------------------------------------------------------------------------------------------------------
1002.13              3628--General             900                1                900           26       23,400
                     3634--TV       ..............  ..................  ..............  ...........  ...........
                     3638--Diagnos  ..............  ..................  ..............  ...........  ...........
                      tic X-ray

[[Page 8749]]

 
                     3641--Cabinet  ..............  ..................  ..............  ...........  ...........
                      X-ray
                     3643--Microwa  ..............  ..................  ..............  ...........  ...........
                      ve Oven
                     3636--Laser    ..............  ..................  ..............  ...........  ...........
                     3631--Sunlamp  ..............  ..................  ..............  ...........  ...........
                     3647--Mercury  ..............  ..................  ..............  ...........  ...........
                      Vapor Lamp
                     3645--Ultraso  ..............  ..................  ..............  ...........  ...........
                      nic Therapy
----------------------------------------------------------------------------------------------------------------
1002.13              .............             250                2.4              600          0.5          300
----------------------------------------------------------------------------------------------------------------
1002.20              3649--ARO                  40                1                 40            2           80
----------------------------------------------------------------------------------------------------------------
1002.41(a)           .............               1                1                  1            1            1
----------------------------------------------------------------------------------------------------------------
1002.50(a) and       3642--General              10                1.5               15            1           15
 1002.51              Corresponden
                      ce
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1005.10              2767--Sample              145               11.03           1,600         0.09          144
                      Product
----------------------------------------------------------------------------------------------------------------
1005.25(b)           .............               1                1                  1            1            1
----------------------------------------------------------------------------------------------------------------
                     2877--Imports             600               32             19,200          0.2        3,840
                      Declaration
----------------------------------------------------------------------------------------------------------------
1010.2 and 1010.3    .............               1                1                  1            5            5
----------------------------------------------------------------------------------------------------------------
1010.4(b)            3633--General               1                1                  1          120          120
                      Variance
                      Request
                     3147--Laser    ..............  ..................  ..............  ...........  ...........
                      Show
                      Variance
                      Request
                     3635--Laser    ..............  ..................  ..............  ...........  ...........
                      Show
                      Notification
----------------------------------------------------------------------------------------------------------------
1010.5(c) and (d)    .............               2                1                  2           22           44
----------------------------------------------------------------------------------------------------------------
1010.13              .............               1                1                  1           10           10
----------------------------------------------------------------------------------------------------------------
1020.20(c)(4)        .............               1                1                  1            1            1
----------------------------------------------------------------------------------------------------------------
1020.30(d), (d)(1),  2579--Assembl           2,345                8.96          21,000         0.30        6,300
 and (d)(2)           er Report
----------------------------------------------------------------------------------------------------------------
1020.30(g)           .............             200                1.33             265           35        9,275
----------------------------------------------------------------------------------------------------------------
1020.30(h)(1)        .............             200                1.33             265           35        9,275
 through (h)(4) and
 1020.32(a)(1) and
 (g)
----------------------------------------------------------------------------------------------------------------
1020.30(h)(5) and    .............              20                5                100          180       18,000
 (h)(6) and
 1020.32(j)(4)
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1020.32(g) and       .............               9                1.00               9           40          360
 1020.33(c), (d),
 and (g)(4)
----------------------------------------------------------------------------------------------------------------
1020.40(c)(9)(i)     .............               8                1.00               8           40          320
 and (c)(9)(ii)
----------------------------------------------------------------------------------------------------------------
1030.10(c)(4)        .............              41                1.61              66           20        1,320
----------------------------------------------------------------------------------------------------------------
1030.10(c)(5)(i)     .............              41                1.61              66           20        1,320
 through (c)(5)(iv)
----------------------------------------------------------------------------------------------------------------
1030.10(c)(6)(iii)   .............               1                1                  1            1            1
 and (c)(6)(iv)
----------------------------------------------------------------------------------------------------------------
1040.10(a)(3)(i)     3637--OEM                  83                1                 83            3          249
                      Report
----------------------------------------------------------------------------------------------------------------
1040.10(h)(1)(i)     .............             805                1.00             805            8        6,440
 through (h)(1)(vi)
----------------------------------------------------------------------------------------------------------------
1040.10(h)(2)(i)     .............             100                1.00             100            8          800
 and (h)(2)(ii)
----------------------------------------------------------------------------------------------------------------

[[Page 8750]]

 
1040.11(a)(2)        .............             190                1.00             190           10        1,900
----------------------------------------------------------------------------------------------------------------
1040.20(d)(1)(ii)    .............             110                1.00             110           10        1,100
 through (d)(1)(vi)
 and (e)(1) and
 (e)(2)
----------------------------------------------------------------------------------------------------------------
1040.30(c)(1)(ii)    .............               1                1.00               1            1            1
----------------------------------------------------------------------------------------------------------------
1040.30(c)(2)        .............               7                1.00               7            1            7
----------------------------------------------------------------------------------------------------------------
1050.10(d)(1)        .............              10                1.00              10           56          560
 through (d)(4) and
 (f)(1) through
 (f)(2)(iii)
----------------------------------------------------------------------------------------------------------------
Total                                                                                                    107,209
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


                                                   Table 2.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                            No. of       Annual Frequency  per     Total Annual
                   21 CFR Section                       Recordkeepers        Recordkeeping           Records        Hours per  Record     Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
1002.30 and 1002.31(a)                                            1,150                1,655.5          1,903,825               198.7            228,505
--------------------------------------------------------------------------------------------------------------------------------------------------------
1002.40 and 1002.41                                               2,950                   49.2            145,140                 2.4              7,080
--------------------------------------------------------------------------------------------------------------------------------------------------------
1020.30(g)                                                           22                    1                   22                 0.5                 11
--------------------------------------------------------------------------------------------------------------------------------------------------------
1040.10(a)(3)(ii)                                                    83                    1                   83                 1.0                 83
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Totals                                                                                                                                           235,679
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    The information collection requirements under OMB control number 
0910-0564 and Form FDA 3626, the data collection instrument for this 
collection, have been consolidated under the information collection 
activity of OMB control number 0910-0025, thus resulting in an 
adjustment (increase) in the current burden estimate.
    The burden estimates were derived by consultation with FDA and 
industry personnel and actual data collected from industry. An 
evaluation of the type and scope of information requested was also used 
to derive some time estimates. For example, disclosure information 
primarily requires time only to update and maintain existing manuals. 
Initial development of manuals has been performed except for new firms 
entering the industry. When information is generally provided to users, 
assemblers, or dealers in the same manual, they have been grouped 
together in the ``Estimated Annual Reporting Burden'' table (table 1 of 
this document).
    The following information collection requirements are not subject 
to review by OMB because they do not constitute a ``collection of 
information'' under the PRA: Sections 1002.31(c); 1003.10(a), (b), and 
(c); 1003.11(a)(3) and (b); 1003.20(a) through (h); 1003.21(a) through 
(d); 1003.22(a) and (b); 1003.30(a) and (b); 1003.31(a) and (b); 
1004.2(a) through (i); 1004.3(a) through (i); 1004.4(a) through (h); 
1005.21(a) through (c); and 1005.22(b). These requirements ``apply to 
the collection of information during the conduct of general 
investigations or audits'' (5 CFR 1320.4(b)). The following labeling 
requirements are also not subject to review under the PRA because they 
are a public disclosure of information originally supplied by the 
Federal Government to the recipient for the purpose of disclosure to 
the public (1410.10 of the FDA Staff Manual Guide and Sec. Sec.  
1020.10(c)(4), 1030.10(c)(6), 1040.10(g), 1040.30(c)(1), and 
1050.10(d)(1)).

    Dated: February 20, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-3258 Filed 2-26-07; 8:45 am]
BILLING CODE 4160-01-S